Jardiance
An oral therapy for type-2 diabetes, heart failure and kidney disease.
Where Empagliflozin is approved
All regulators →Of the three regulators tracked here, the first to approve Empagliflozin was the EU, on 22 May 2014. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Empagliflozin patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Empagliflozin, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 15 listed patents; the last listed expires 11 Dec 2034 (US 9949998, including a 6-month paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 20 Dec 2026.
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Empagliflozin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Empagliflozin works
All drug targets →- Sodium/glucose cotransporter 2 inhibitor InhibitorTarget: SLC5A2 solute carrier family 5 member 2✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- COVID-19–associated multisystem inflammatory syndrome in childrenPhase 3
- HypoglycemiaPhase 3
- Impaired glucose tolerancePhase 3
- Increased body weightPhase 3
- Orthomyxoviridae infectious diseasePhase 3
- ShockPhase 3
- Acute myocardial infarctionPhase 3
- Cardiovascular disorderPhase 3
- Diabetic kidney diseasePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2107830, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 4754, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Empagliflozin
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 6 technology appraisals of Empagliflozin. 6 are current, and 5 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Empagliflozin for treating type 2 diabetes in people 10 to 17 years (terminated appraisal) NICE TA1006 | Terminated (no company submission) | 12 Sep 2024 | Current |
| Empagliflozin for treating chronic kidney disease NICE TA942 | Optimised | 20 Dec 2023 | Current |
| Empagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction NICE TA929 | Recommended | 1 Nov 2023 | Current |
| Empagliflozin for treating chronic heart failure with reduced ejection fraction NICE TA773 | Optimised | 9 Mar 2022 | Current |
| Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes NICE TA390 | Optimised | 25 May 2016 | Current |
| Empagliflozin in combination therapy for treating type 2 diabetes NICE TA336 | Recommended | 25 Mar 2015 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Empagliflozin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- EUEuropean Union: JardianceEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Empagliflozin
- ChEMBL
- CHEMBL2107830
- DrugBank
- DB09038
- PubChem CID
- 11949646
- CAS number
- 864070-44-0
- FDA UNII
- HDC1R2M35U
- Wikidata
- Q5373824
- Wikipedia
- Empagliflozin
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Jardiance is used for
JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. ( 1 ) To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended in patients with type 1 diabetes mellitus. It may increase the risk o…
How it works
12.1 Mechanism of Action Empagliflozin is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2), the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions such as lowering both pre-and afterload of the heart and downregulating sympathetic activity.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 9 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.